COMPARISON OF THE EFFICACY OF ONE LEVEL AND TWO LEVEL OF BILATERAL THORACIC ERECTOR SPINAE PLANE BLOCK COMBINED WITH GENERAL ANESTHESIA IN LAPAROSCOPIC BARIATRIC SURGERY FOR OBESE PATIENTS: RANDOMIZED CONTROLLED TRIAL
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- • Comparison of mean visual analog scale scores at 24 hours postoperative between study groups
研究概览
简要总结
The study is to evaluate effectiveness of one-level versus two-level thoracic ESP block on intraoperative and postoperative analgesia in bariatric surgeries and to compare total opioid consumption of both groups.
详细描述
The prevalence of overweight and obesity is steadily increasing. The epidemic of overweight and obesity presents a major challenge to chronic disease prevention and health across the life course around the world.
Bariatric surgery has proved to be an efficient intervention in the management of obesity. As a result, the number of post-bariatric surgery patients in the population is growing .
Postoperative pain is categorized into acute pain which occur immediately after surgery (up to 7 days) and chronic pain which lasts more than 3 months after the injury . Laparoscopic bariatric surgery often presents significant pain, ranging from moderate to severe, particularly in the immediate time following the operation, it is estimated that 75% of patients experience moderate pain post laparoscopic bariatric surgeries .
Postoperative pain is divided into four types according to cause, Nociceptive Pain is the signal of tissue irritation, impending injury, or actual injury. Neuropathic Pain is the result of the nervous system injury or malfunction, either in the peripheral or in the central nervous system, Psychogenic Pain due to the psychological factors leading to an exaggerated or histrionic presentation of the pain problem, Mixed Category Pain is caused by a complex mixture of nociceptive and neuropathic factors .
Due to the higher risk of respiratory depression, administering opioids to morbidly obese individuals might provide significant challenges when it comes to delivering pain relief .
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient age ranges 18 to 60 years old
- •Obese patients ; Body mass index(BMI) ≥ 35 - 50 kg/m2
- •American Society of Anesthesiologists (13) physical status classes II to III
- •Patients scheduled for laparoscopic bariatric surgery i.e. sleeve gastrectomy and/or Roux-en-Y gastric bypass (RYGB) surgeries
排除标准
- •• Refusal of regional block
- •Patients with neurological, psychological disorders or those lacking cooperation.
- •Patients scheduled for concomitant laparoscopic cholecystectomy or paraumbilical hernia repair or those with history of previous bariatric surgery or obstructive sleep apnea.
- •Patients with anatomic abnormalities at site of injection, skin lesions or wounds at site of proposed needle insertion.
- •Patients with bleeding disorders defined as (INR >1.4) and/ or (platelet count <100,000/µL)
- •Patients with hepatic disease e.g. liver cell failure or hepatic malignancy or hepatic enlargement.
- •Patients who are allergic to amide local anesthetics
结局指标
主要结局
• Comparison of mean visual analog scale scores at 24 hours postoperative between study groups
时间窗: 24 hours
次要结局
- Time for first rescue analgesia in both groups(24 hours)
- b) Total opioid consumption in both groups in 24hr postoperative(24 hours)
- Failure rate in performing the block(24 hours)
研究者
Belal Galal Mostafa Mohammed Khater
Assistant lecturer
Cairo University